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Dermapure

2150 - 1800 194 Avenue SE Calgary AB T2X 0R3 · Personal Services

5 inspections

  1. Demand Inspection

    1 infraction

    • 26. Are cosmetic products appropriate for their intended use and being handled properly?
      • Facility is providing Derive and Exo E. Health Canada communicated to EPH that no exosome products, including plant based, are approved for use in Canada. Provide written approval for use of this product or that this product is not banned from Health Canada.
  2. Risk Management Inspection

    0 infractions

  3. Risk Management Inspection

    3 infractions

    • 22. If the facility sterilizes equipment, are all proper sterilization, verification, and documentation processes in place (Critical)?
      • 1. There is no procedure in place to monitor the sterilization cycle (e.g., sterilization temperature, exposure time at the sterilization temperature, and pressure). The current sterilizer is not equipped with a data logger or printer to provide a means of monitoring these cycle parameters. Please obtain a sterilizer that can provide electronic data or a printout, or designate someone to monitor the parameters during the sterilization cycle.
    • 23. If the facility sterilizes equipment, are all proper sterilization, verification, and documentation processes in place (Non-Critical)?
      • 1. No load number is assigned to packages when multiple loads are run in one day. Please assign an identifier for each load.
    • 26. Are cosmetic products appropriate for their intended use and being handled properly?
      • 1. The opened and used Lidocaine vial is not dated. Please refer to the manufacturer's instructions for the shelf-life of the product after opening and ensure that the date of opening is clearly labeled on the vial.2. The opened and used saline containing preservative is not dated. Kindly verify the manufacturer's instructions regarding the shelf-life of saline after opening and label the vial with the date of opening.3. Neuromodulators (e.g., Botox and Dysport) are currently being reconstituted with saline containing preservatives. Please follow the manufacturer's instructions, which specify that the product should be reconstituted using non-preservative saline.Lastly, please update the current policy and procedure for cosmetic injections to reflect the above corrective actions.
  4. Risk Management Inspection

    3 infractions

    • 22. If the facility sterilizes equipment, are all proper sterilization, verification, and documentation processes in place (Critical)?
      • 1. There is no procedure in place to monitor the sterilization cycle (e.g., sterilization temperature, exposure time at the sterilization temperature, and pressure). The current sterilizer is not equipped with a data logger or printer to provide a means of monitoring these cycle parameters. Please obtain a sterilizer that can provide electronic data or a printout, or designate someone to monitor the parameters during the sterilization cycle.2. There was no cleaning brush available to indicate that devices were properly cleaned before sterilization. Please obtain appropriate cleaning tool.
    • 23. If the facility sterilizes equipment, are all proper sterilization, verification, and documentation processes in place (Non-Critical)?
      • 1. No load number is assigned to packages when multiple loads are run in one day. Please assign an identifier for each load.
    • 26. Are cosmetic products appropriate for their intended use and being handled properly?
      • 1. The opened and used Lidocaine vial is not dated. Please refer to the manufacturer's instructions for the shelf-life of the product after opening and ensure that the date of opening is clearly labeled on the vial.2. The opened and used saline containing preservative is not dated. Kindly verify the manufacturer's instructions regarding the shelf-life of saline after opening and label the vial with the date of opening.3. Neuromodulators (e.g., Botox and Dysport) are currently being reconstituted with saline containing preservatives. Please follow the manufacturer's instructions, which specify that the product should be reconstituted using non-preservative saline.Lastly, please update the current policy and procedure for cosmetic injections to reflect the above corrective actions.
  5. Initial Inspection

    3 infractions

    • 22. If the facility sterilizes equipment, are all proper sterilization, verification, and documentation processes in place (Critical)?
      • 1. Expired biological indicators are being used. Please replace them immediately.2. The marker used for labeling pouch packages has not been validated for sterilization. Please obtain an appropriate marker that is validated for this purpose.3. There is no procedure in place to monitor the sterilization cycle (e.g., sterilization temperature, exposure time at the sterilization temperature, and pressure). The current sterilizer is not equipped with a data logger or printer to provide a means of monitoring these cycle parameters. Please obtain a sterilizer that can provide electronic data or a printout, or designate someone to monitor the parameters during the sterilization cycle.4. There was no cleaning brush available to indicate that devices were properly cleaned before sterilization. Please obtain appropriate cleaning tool.
    • 23. If the facility sterilizes equipment, are all proper sterilization, verification, and documentation processes in place (Non-Critical)?
      • 1. No load number is assigned to packages when multiple loads are run in one day. Please assign an identifier for each load.
    • 26. Are cosmetic products appropriate for their intended use and being handled properly?
      • 1. The opened and used Lidocaine vial is not dated. Please refer to the manufacturer's instructions for the shelf-life of the product after opening and ensure that the date of opening is clearly labeled on the vial.2. The opened and used saline containing preservative is not dated. Kindly verify the manufacturer's instructions regarding the shelf-life of saline after opening and label the vial with the date of opening.3. Neuromodulators (e.g., Botox and Dysport) are currently being reconstituted with saline containing preservatives. Please follow the manufacturer's instructions, which specify that the product should be reconstituted using non-preservative saline.Lastly, please update the current policy and procedure for cosmetic injections to reflect the above corrective actions.